- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05074979
Telerehabilitation in COVID-19 Survivors
Determining the Effectiveness of Telerehabilitation in COVID-19 Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Canan Demir
- Phone Number: +905458070601
- Email: canandemir@bandirma.edu.tr
Study Locations
-
-
Bandırma
-
Balıkesir, Bandırma, Turkey, 10200
- Bandırma Onyedi Eylül University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with COVID-19 by Computed Tomography (CT) or PCR test between the ages of 18-75,
- Do not have any orthopedic or neurological disease that will affect exercise capacity,
- Individuals who can take and execute verbal orders,
- Have had COVID-19 and at least 2 weeks have passed since the completion of the treatment,
- Individuals who have a computer or smart phone with a camera and internet connection and have the ability to use it (the participant himself or one of his family members living in the same house),
- Individuals who are sedentary (those whose physical activity level is inactive according to the Turkish version of the International Physical Activity Questionnaire (UFAA)),
- Having dyspnea at level 2 or 3 on the Medical Research Council Dyspnea Scale.
Exclusion Criteria:
- Those who have not had COVID-19 or acute period patients who are experiencing COVID-19,
- Individuals who cannot be contacted,
- Individuals with chronic heart disease,
- Those with concomitant uncontrolled disease; uncontrolled hypertension (resting blood pressure ≥160 /100mmHg), uncontrolled diabetes (random instantaneous blood glucose>16.7 mmol/l, HbA1C>7.0%),
- Those with concomitant severe organic disease (unstable hemodynamic heart disease, heart failure causing movement limitation, unstable angina, MI or other cardiac disease in the last 12 years),
- Individuals with cerebrovascular disease in the last 6 months,
- Those with digestive system ulcer, thyroid dysfunction or active stage of tuberculosis,
- Patients with Chronic Kidney Failure stage 3 and above according to Glomerular Filtration Rate (GFR),
- Individuals who have undergone intraraticular medication or surgery from their lower extremities in the last 6 months,
- Individuals who cannot walk independently,
- Individuals with any mental illness that may prevent them from living independently or receiving treatment,
- Uncooperative individuals for assessment and rehabilitation programs,
- Those with alcohol or substance addiction,
- Those who are pregnant, suspected of pregnancy or considering becoming pregnant,
- Participants in another study within the last 3 months or currently.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: control group
While other groups continue their exercise program for 6 weeks, this group will only be informed after COVID 19.
|
will informed after COVID 19
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Experimental: home exercise program group
this group will implement COVID 19 home exercise program.
|
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
|
Experimental: telerehabilitation group
this group will implement COVID 19 telerehabilitation program.
|
While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Severity of dyspnea assessment
Time Frame: 6 weeks
|
Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea.
The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.
|
6 weeks
|
Physical activity level assessment
Time Frame: 6 weeks
|
The physical activity level of the participants will be evaluated with the Turkish version of the "International Physical Activity Questionnaire" (UFAA).In the last 7 days with the survey; Vigorous physical activity (football, basketball, aerobics, cycling fast, lifting weights, carrying loads, etc.) time (min), Intermediate physical activity (light weight carrying, cycling at normal speed, folk dances, dancing, bowling, table tennis etc.) duration (min), walking and sitting times for one day (min) are questioned.
All participants were given pre-study to assess the condition of being sedentary and those with inactive physical activity levels will be included in the study.
|
6 weeks
|
Cardiopulmonary endurance assessment
Time Frame: 6 weeks
|
In order to evaluate cardiopulmonary endurance; A six-minute walking test will be applied.
The test is 30 meters long, every 3 meters marked, the start and finish line are marked by a visible line, a smooth and straight done on the track.
The distance the person walks for 6 minutes is recorded in meters.
|
6 weeks
|
Evaluation of peripheral muscle oxygenation
Time Frame: 6 weeks
|
"Moxy muscle oxygen monitor" will be used to measure regional oxygen saturation (SmO2) and total hemoglobin (Thb) amount in capillaries under the muscle.
Moxy muscle oxygen monitor (Fortiori Design LLC, USA) near infrared It is placed on the skin in a non-invasive way with spectroscopy (NIRS), It is a device that regional blood flow and measures oxygenation.
A moxy muscle oxygen monitor will be attached to the quadriceps femoris muscle of the participants with a velcro and oxygenation measurements will be taken during both the dinelnim and 6-minute walking test.
|
6 weeks
|
Pulmonary function (slow vital capacity)
Time Frame: 6 weeks
|
Single Breath Count Test will be used to evaluate slow vital capacity (the amount of air exhaled with slow exhalation after deep and maximal inspiration) and lung function. Single breath count (TNS), after maximal effort inhalation an individual with a metronome set to 2 beats per second in a normal speaking voice. It is a measure of how much you can count in your cadence. |
6 weeks
|
Pulmonary function (Forced vital capacity (FVC))
Time Frame: 6 weeks
|
Pulmonary function will be evaluated with the spirometry.
Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
With the device, forced vital capacity (FVC) will be evaluated.
|
6 weeks
|
Respiratory Muscle Strength
Time Frame: 6 weeks
|
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using portable, electronic, oral pressure measuring device.
|
6 weeks
|
Activities of daily living assessment
Time Frame: 6 weeks
|
Barthel Index will be used to evaluate activities of daily living.
|
6 weeks
|
Muscle strength assessment
Time Frame: 6 weeks
|
Upper and lower extremity muscle strengths will be measured using a manual muscle strength measuring device.
|
6 weeks
|
Perceived fatigue assessment
Time Frame: 6 weeks
|
Participants' perceived fatigue level will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers. consists of corresponding definitions It will be recorded using the "Fatigue Scale". Developed by Borg, modified The category ratio scale (BORG CR-10 SCAL) with 10 degrees in shape is given to certain numbers consists of corresponding definitions. The Borg Scale is a subjective scale used to evaluate muscle fatigue. |
6 weeks
|
General fatigue assessment
Time Frame: 6 weeks
|
Participants will be asked to answer the chalder fatigue scale, which includes 11 questions about their fatigue in the past month.
The maximum total score is 33; 4 and above scorers are described as tired.
|
6 weeks
|
Quality of life assessment
Time Frame: 6 weeks
|
The Short Form-12 (SF-12) Questionnaire will be used to assess the quality of life.When scoring, two scores are obtained, the physical component and the mental component summary. is done. High scores indicate good health. |
6 weeks
|
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time Frame: 6 weeks
|
Pulmonary function will be evaluated with the spirometry.
Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
|
6 weeks
|
Pulmonary function (FEV1 / FVC)
Time Frame: 6 weeks
|
Pulmonary function will be evaluated with the spirometry.
Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
With the device, FEV1 / FVC will be evaluated.
|
6 weeks
|
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time Frame: 6 weeks
|
Pulmonary function will be evaluated with the spirometry.
Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
|
6 weeks
|
Pulmonary function (Peak flow rate (PEF)
Time Frame: 6 weeks
|
Pulmonary function will be evaluated with the spirometry.
Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.
With the device, peak flow rate (PEF) will be evaluated.
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDemir
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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